Associate Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‑IO

Associate Director Quantitative Pharmacology And Pharmacometrics – Immune/Oncology

Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are recognized as an industry leader in immuno-oncology (IO) and vaccines discovery and development. For more than a century, our company has translated scientific innovation into medicines and vaccines that improve and save lives worldwide—anchored in ethical integrity, scientific excellence, and a clear mission to transform global health.

Our company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Our Research & Development Division is a world-class scientific organization that brings together leading discovery capabilities and small molecule/biologics R&D expertise to create breakthrough science and redefine how we treat serious diseases.

Role Overview

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Associate Director. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.

Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions.

They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions on drug development teams.

Primary Responsibilities:

• Serving as an expert representative for QP2-IO on Oncology clinical development teams.
• Framing critical questions for optimizing model-based analyses on programs.
• Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
• Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.

• Ph.D. with at least 3 years of experience

OR

• PharmD or MS or equivalent degree with preferably 5-7 years of relevant experience, where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.

• Demonstrated impactful experience with applications of pharmacometrics methods.
• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• Proficiency in R, NONMEM or other similar programming language.
• Professional working proficiency in written and verbal communication.